SBIR-STTR Award

Phase I involves manufacturing and testing a Rolling Joint Prosthetic Leg (RJ Leg), comprisingly a newly developed Rolling Joint Foot (RJ Foot) and Rolling Joint Knee (RJ Knee). Prosthetic rolling joints will significantly impact the comfort and independence of the transtibial and transfemoral amputees and increase the number of persons, especially elderly, able to wear lower limb prostheses. The specific aims of the project. (1) Manufacture the RJ Knee prototype, which mechanism yields a resistive curve similar to the biological knee joint. (2) Mechanically test stance flexion of the RJ Knee, and shock absorption, rotational stiffness and eversion/inversion of the RJ Foot. (3) Conduct a biomechanical study of 405 transfemoral (AK) amputees wearing a RJ Leg prototype and comparing it to their existing prostheses on: normalizing range of motion in the knee joint; decreased peak pressures between residuum and a socket. This will increase functionality of the leg prosthesis by normalizing the synergetic relationship between the motion in prosthetic ankle and knee during the stance phase of the gait. Long term objectives of the proposed research, are to: develop a functional, reliable and economical prosthetic leg modular system, and a system for synergetic alignment of the components. PROPOSED COMMERCIAL APPLICATION Potential commercial applications is the creation of a product line of Rolling Joint Feet and Knees. The RJ Leg will enhance performance of amputees without increasing cost, thus providing a highly competitive product in the field of prosthetic rehabilitation

The Phase II project is to complete development of a new Rolling Joint Prosthetic Leg comprising a Rolling Joint (Free-Flow) Foot and Ankle and the Rolling Joint Prosthetic Knee. Original design of both prostheses is based on a Rolling Joint Technology, recently developed by the applicants. The Rolling Joint Foot and Ankle was commercialized in October of 1999. Major efforts during the Phase I of the current study were developed to design, manufacture and testing of the new Rolling Joint Knee. As results of the Phase I study showed, development of Rolling Joint Prosthetic Leg has merit to be continued. Development and testing of the Rolling Joint Knee will be completed during the Phase II proposed. Additional research will be conducted to verify the hypothesis that patients with trans-femoral amputations will benefit from aan assembly of both Rolling Joint Units in a Rolling Joint Leg. New methodology for individual tuning of critical parameters of prostheses will be developed. It will provide more normal, less painful locomotion in a lower limb amputee and increase number of patients to be managed prosthetically. The specific aims of the Phase II project. Complete a development of a new Knee unit prototype with compliant tibial component; conduct a comparative mechanical tests and biomechanical gait study with 20 trans-femoral amputees to verify the hypothesis that a new prosthetic device with the proposed mechanical outcome improves a trans-femoral amputee gait by normalizing "stump-socket" interface during stance phase of gait. Long term objectives of the proposed research are to develop a functional, reliable and economical prosthetic modular system. PROPOSED COMMERCIAL APPLICATIONS: Potential commercial application is the creation of a product line of Rolling Joint Feet and Knees. The RJ Leg will enhance performance of transfemoral amputees without increasing the cost, thus providing a highly competitive product in the field of prosthetic rehabilitation.

Thesaurus Terms:
artificial limb, biomechanics, biomedical equipment development, joint prosthesis amputation, ankle, biomaterial interface interaction, clinical biomedical equipment, foot, knee bioengineering /biomedical engineering, clinical research, human subject, patient oriented research